AD, Quality Assurance - Engineering
RBW are seeking an AD, Quality Assurance - Engineering join a nonprofit social welfare entity with over 6 years in the industry, born out of the need to address the critical shortage of essential injectable medications in the U.S. healthcare system. Now they are dedicated to the development and manufacture of Insulin to create a more affordable and accessible healthcare system. You will play a critical role at a state-of-the-art fill-finish facility, dedicated to the production of essential generic sterile and biosimilar injectable medications.
Quality System Oversight: Establish and uphold quality processes for GMP compliance across the facility, equipment, and manufacturing processes through cross-functional collaboration.
Operational Readiness: Lead efforts to prepare for Health Agency inspections and ensure that facilities and processes comply with all relevant regulations.
Quality Management: Oversee various quality processes across the product lifecycle, including change control, corrective actions, deviations, and investigations.
The organization is committed to alleviating the critical shortages of generic sterile and biosimilar injectable medications in the U.S. healthcare system. By leading quality assurance efforts, the Associate Director directly contributes to increasing the availability of these vital medications, which can be lifesaving for patients in need.
If you would like to hear more about this Senior position with a growing organisation, please get in touch with Cloe to organise a call.